An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission (ED_SMART)

An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior

The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.

Study Overview

• Status: Recruiting
• Conditions: Suicidal and Self-injurious Behavior; Linkage to Care
• Intervention / Treatment: Behavioral: adaptive intervention

Detailed Description

This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Hasbro Children's Hospital
      • Contact: Mary Kathryn Cancilliere, PhD; Phone Number: 401-444-7443; Email: marykathryn.cancilliere@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Youth 8 to 17 years
• Youth presenting to the ED with suicide and self-injurious behavior
• Youth living at home with at least one legal guardian/caregiver

Exclusion Criteria:

• Youth presenting to the ED with psychosis, sexual assault, child abuse
• Youth in police custody,
• Youth with an active investigation with the department of child and youth services (DCYF)
• Youth unable to assent due to severity of illness or developmental disabilities,
• Youth who cannot communicate in English or Spanish,
• Youth without a caregiver/legal guardian who can provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial; Digitally delivered psychosocial	Behavioral: adaptive intervention; We will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only.
Experimental: Psychosocial with text messages; Digitally delivered psychosocial with text messages	Behavioral: adaptive intervention; We will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only.
Experimental: Psychosocial with text messages and family navigator; Digitally delivered psychosocial with text messages and human family navigator	Behavioral: adaptive intervention; We will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)	3-month & 6-month follow-up assessments
Child and Adolescent Service Assessment (CASA)	Youth Attendance to Community-based Mental Health Care. CASA question and caregiver report of youth attendance in behavioral health care/community-based mental health services (yes or no) after discharge from emergency department admission.	3-month and 6-month follow-up assessments
Intervention Acceptability	Client Satisfaction Questionnaire. An 8-item questionnaire that provides (positive & negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.	3-month and 6-month follow-up assessments

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Cancilliere MK, Ramanathan A, Hoffman P, Jencks J, Spirito A, Donise K. Characteristics of a Pediatric Emergency Psychiatric Telephone Triage Service. Pediatr Emerg Care. 2022 Oct 1;38(10):494-501. doi: 10.1097/PEC.0000000000002831. Epub 2022 Aug 18.
• Spirito A, Simon V, Cancilliere MK, Stein R, Norcott C, Loranger K, Prinstein MJ. Outpatient psychotherapy practice with adolescents following psychiatric hospitalization for suicide ideation or a suicide attempt. Clin Child Psychol Psychiatry. 2011 Jan;16(1):53-64. doi: 10.1177/1359104509352893. Epub 2010 Apr 19.
• Cancilliere MK, Donise K. A Comparison of Acute Mental Health Presentations to Emergency Services Before and During the COVID-19 Pandemic. R I Med J (2013). 2022 May 2;105(4):9-15.
• Cancilliere MK, Guthrie KM, Donise K, Lin T, Orchowski L, Spirito A. Development of an Emergency Department Family Navigator and Text Message Intervention for Caregivers to Reduce Youth Risk of Suicide and Self-injurious Behavior. R I Med J (2013). 2024 Aug 1;107(8):28-38.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: caregivers; emergency department; youth; suicidality; self-injurious behavior; adaptive intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 2037770; K23MH136332 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No